CN114786691A - 用于治疗艰难梭菌感染的营养组合物 - Google Patents
用于治疗艰难梭菌感染的营养组合物 Download PDFInfo
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- CN114786691A CN114786691A CN202080079544.5A CN202080079544A CN114786691A CN 114786691 A CN114786691 A CN 114786691A CN 202080079544 A CN202080079544 A CN 202080079544A CN 114786691 A CN114786691 A CN 114786691A
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- milk oligosaccharides
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Abstract
营养组合物包含岩藻糖基化人乳寡糖和/或唾液酸化人乳寡糖、不可消化的可发酵多糖和双歧杆菌。营养组合物不含具有至少约50%的聚合度小于约5的分子的短链果寡糖。治疗有罹患艰难梭菌感染风险的受试者或患有艰难梭菌感染的受试者的方法包括施用此类营养组合物。
Description
技术领域
本公开涉及用于治疗有罹患艰难梭菌(Clostridium difficile)感染(CDI)风险的受试者或患有CDI的受试者的营养组合物。本公开还涉及用于治疗有罹患CDI风险的受试者或患有CDI的受试者的营养组合物和方法。
背景技术
艰难梭菌(CD)是一种厌氧、产芽孢、产毒的***,其通过粪口途径在人类之间传播。肠道微生物群被抗生素疗法破坏的老年免疫功能低下的个体感染这种高度传染性、危及生命且可能致命的腹泻病的风险最大。在21世纪初开始出现高毒力菌株后,CD成为一种主要的、全球分布的肠道病原体。
通常,CD被认为是医院获得的院内病原体。然而,该疾病现在更频繁地出现在曾经被认为处于低风险的个体中。这些病例往往发生在年轻个体身上。最近的抗生素暴露是该人群的一个重要风险因素,但胃酸抑制剂的使用和诸如炎性肠病、慢性肾病、免疫缺陷病、恶性病变和实体器官移植的合并症也与CDI相关。
目前,CDI的标准治疗物是抗生素,其中万古霉素或非达霉素是最常用的处方化合物。只有万古霉素或非达霉素不可用时才使用甲硝唑。粪便微生物群移植(FMT)仅作为多次复发后的最后手段。益生菌也被用作预防性治疗物,结果喜忧参半。目前还没有疫苗可用。在医疗保健机构中,预防措施包括合理使用抗生素和感染控制措施。还研究了单克隆抗体的使用,目的是提高宿主对CDI的抵抗力,但是这种方法产生了好坏参半的结果。
本领域需要给受试者带来改善的健康益处的更好的治疗方式。本发明提供了用于降低CD感染的发生率并改善受试者结局的营养组合物和方法。
发明内容
根据本公开,提供了营养组合物。营养组合物包含岩藻糖基化人乳寡糖和/或唾液酸化人乳寡糖、不可消化的可发酵多糖和双歧杆菌(Bifidobacterium)。营养组合物不含具有至少约50%的聚合度小于约5的分子的短链果寡糖(scFOS)。
根据本公开,提供了一种治疗有罹患CDI风险的受试者或患有CDI的受试者的方法。该方法包括向受试者施用营养组合物,所述营养组合物包含岩藻糖基化人乳寡糖和/或唾液酸化人乳寡糖、不可消化的可发酵多糖和双歧杆菌。营养组合物不含具有至少约50%的聚合度小于约5的分子的scFOS。
附图说明
图1例示了来自使用如本文所述的评估CDI和复发的胃肠(GI)道体外模型的对照(对照A)实验的结果;
图2例示了来自使用如本文所述的评估CDI和复发的GI道体外模型的对照(对照B)实验的结果;
图3例示了来自使用GI道体外模型在用特定人乳寡糖(HMO)、玉米纤维(纤维2)和***树胶(纤维3)以及益生菌治疗后评估CDI和复发的实验的结果;
图4例示了来自使用GI道体外模型在用益生菌治疗后评估CDI和复发的实验的结果;
图5例示了来自使用GI道体外模型在用HMO治疗后评估CDI和复发的实验的结果;
图6例示了来自使用GI道体外模型在用scFOS(纤维1)和纤维2和3治疗后评估CDI和复发的实验的结果;
图7例示了来自使用GI道体外模型在用HMO和纤维2和3治疗后评估CDI和复发的实验的结果;
图8例示了来自使用GI道体外模型在用HMO和纤维1、2和3治疗后评估CDI和复发的实验的结果;
图9例示了来自使用GI道体外模型在用纤维1、2、3和益生菌治疗后评估CDI和复发的实验的结果;
图10例示了来自使用GI道体外模型在用HMO和益生菌治疗后评估CDI和复发的实验的结果;
图11例示了来自使用GI道体外模型在用HMO、纤维1、2、3和益生菌治疗后评估CDI和复发的实验的结果;和
图12例示了来自使用GI道体外模型在用纤维2和3治疗后评估CDI和复发的实验的结果;
具体实施方式
现在将描述本公开的具体实施方案。然而,本发明可以许多不同形式来实施并且不应被理解为局限于本文中所阐述的实施方案。相反,提供这些实施方案以向本领域技术人员说明本发明的某些方面的更具体的特征。
如本文所阐述的术语仅用于描述实施方案,并且不应被解释为总体上限制本公开。对本公开的单一特征或限制的所有提及应包括相应多个特征或限制,并且反之亦然,除非另有规定或在进行提及的上下文明确暗示相反。除非另有规定,否则“一个/种(a/an)”、“所述”和“至少一个/种”可互换使用。此外,除非上下文另外清楚指示,否则如本说明书和随附权利要求书中所用,单数形式“一个/种(a/an)”和“该/所述(the)”包括其复数形式。
就在本说明书或权利要求中使用术语“包括(includes)”或“包括(including)”来说,其意图以与术语“包含(comprising)”在权利要求中用作过渡词时所解释的类似的方式具有包括性。此外,就所采用的术语“或”(例如,A或B)来说,其意图指“A或B或两者”。当意图“仅A或B而不是两者”时,那么将采用术语“仅A或B而不是两者”。因此,在本文中术语“或”的使用是包括性的,而不是排他性的使用。当术语“和”以及“或”一起使用时,如在“A和/或B”中,这指示A或B以及A和B。
本公开的营养组合物和制备营养组合物的相应方法可包括如本文所述的本公开的任何要素,由如本文所述的本公开的任何要素组成或基本上由如本文所述的本公开的任何要素组成。
本文所公开的所有范围和参数(包括但不限于百分比、份数和比率)应理解为涵盖其中包含的任何和所有子范围以及端点之间的每个数字。例如,所陈述的“1至10”的范围应被认为包括以为1或更大的数的最小值开始并且以为10或更小的数的最大值结束的任何和所有子范围(如1至6.1,或2.3至9.4),并且被认为是包含在该范围内的每个整数(1、2、3、4、5、6、7、8、9和10)。
如本文所用的方法或工艺步骤的任何组合可按任何顺序进行,除非另有规定或提及组合的上下文明确暗示相反。
短语“聚合度”是指分子中单体单元(例如单体糖单元)的数量。除非另有规定,否则如本文所用的短语“具有至少约50%的聚合度为从第一数字到第二数字的分子”是指具有由不同数量的单体糖单元组成的多个分子的成分,其中至少约一半的该分子具有落在从第一数量到第二数量范围内的糖单元数。
除非另有规定,否则如本文所用的术语“不可消化的可发酵多糖”是指具有至少约50%的聚合度大于或等于10的分子的聚合碳水化合物分子,其在小肠中抵抗消化并在大肠中完全或部分发酵。不可消化的可发酵多糖的非限制性实例包括菊粉、***树胶和玉米纤维。本文所述的营养组合物的具体实施方案包含菊粉、***树胶和/或玉米纤维。
除非另有规定,否则如本文所用的术语“寡糖”是指具有至少约50%的聚合度为2至9的分子的碳水化合物分子。
除非另有规定,否则如本文所用的术语“scFOS”是指短链果寡糖,并且更具体地,是指由果糖分子组成的碳水化合物分子,其中scFOS具有至少约50%的聚合度为1至5的分子。
除非另有规定,否则如本文所用的术语“人乳寡糖”(HMO)是指来源于由人分泌的乳汁的寡糖,并且还是指来自非人类哺乳动物(包括但不限于牛科动物、绵羊、猪科动物和/或山羊物种)的乳寡糖。当提及非人类哺乳动物时,如果获得的乳寡糖在结构和/或功能上是等同的,或者是由人分泌的乳寡糖的结构和/或化学类似物,则所述获得的乳寡糖将被视为HMO。在额外的实施方案中,HMO也经由微生物发酵、酶促过程、化学合成或其组合来产生。
除非另有规定,否则如本文使用的术语“益生元”是指通过选择性刺激受试者胃肠(GI)道中细菌的生长和/或活性而有益地影响受试者的不可消化的食物成分。不可消化的可发酵多糖是益生元的实例。
除非另有规定,否则如本文所用的术语“益生菌”是指在消化过程中存活下来从而赋予宿主健康益处的微生物,诸如细菌或酵母菌。可单独或组合包含在本文所述的营养组合物中的益生菌的实例包括双歧杆菌属(Bifidobacterium,B.),诸如短双歧杆菌(B.breve)M-16V、婴儿双歧杆菌(B.infantis)Bb02、婴儿双歧杆菌M-63、婴儿双歧杆菌35624、乳酸双歧杆菌(B.lactis)Bb12、乳酸双歧杆菌HN019、乳酸双歧杆菌Bi07、两歧双歧杆菌(B.bifidum)、长双歧杆菌(B.longum)BB536、长双歧杆菌AH1205、长双歧杆菌AH1206和动物双歧杆菌,及乳杆菌属(Lactobacillus,L.),诸如鼠李糖乳杆菌(L.rhamnosus)GG、鼠李糖乳杆菌HN001、嗜酸乳杆菌(L.acidophilus)LA-5、嗜酸乳杆菌NCFM、发酵乳杆菌(L.fermentum)CECT5716、罗伊氏乳杆菌(L.reuteri)ATCC55730、罗伊氏乳杆菌ATCC PTA-6475和罗伊氏乳杆菌DSM 17938,嗜热链球菌(Streptococcus thermophilus)Th4,阿克曼氏菌属(Akkermansia),拟杆菌属(Bacteroides),肠球菌属(Enterococcus),真杆菌属(Eubacterium),粪杆菌属(Fecalibacterium),罗斯氏菌属(Roseburia)和/或酵母菌属(Saccharomyces)。
如本文所用的短语“管饲营养组合物”是指被配制成经由饲管施用于受试者的胃肠***的营养组合物。可用于施用管饲营养组合物的饲管布置的实例包括但不限于胃管、鼻胃管、空肠管和胃-空肠管。
除非另有规定,否则如本文所用的术语“不含”是指含有小于约1重量%的此类成分的物质。具体实施方案含有小于0.5重量%的所述成分或小于0.25重量%的所述成分。具体实施方案含有小于0.1重量%的所述成分,或不含可测量量的所述成分(即所述成分的量为0重量%)。
本文提供的营养组合物的具体实施方案呈粉末、液体(如,复溶粉末、饮料、油和/或水滴、糖浆(syrup))、固体(如,棒、片剂、胶囊、糖果或口香糖)或半-固体(布丁、糊剂或凝胶)的形式并且是食物或者可以掺入到食物中或者可以包含膳食补充剂。
在具体实施方案中,当营养组合物为液体时,一份(serving)范围为约1ml至约500ml,包括约110ml至约500ml、约110ml至约417ml、约120ml至约500ml、约120ml至约417ml、约177ml至约417ml、约207ml至约296ml、约230m至约245ml、约110ml至约237ml、约120ml至约245ml、约110ml至约150ml,和约120ml至约150ml。在具体实施方案中,一份为约1ml,或约100ml,或约237ml,或约500ml。
在具体实施方案中,当营养组合物是液体、固体、半固体或粉末时(这包括当所述组合物包含粉末或液体补充剂时),所述组合物提供每一份营养组合物至多约500kcal的能量,包括每一份(如本文所述)营养组合物约20kcal至约500kcal、约75kcal至约500kcal、约150kcal至约500kcal、约250kcal至约500kcal、约300kcal至约500kcal或约400kcal至约500kcal的能量。
在具体实施方案中,液体营养组合物的热量密度为约0.5kcal/ml至约3kcal/ml。在具体实施方案中,营养组合物的热量密度为约0.5kcal/ml至约2.5kcal/ml,包括约0.5kcal/ml至约2kcal/ml、约0.5kcal/ml至约1.5kcal/ml、约0.5kcal/ml至约1kcal/ml或约0.5kcal/ml至约0.8kcal/ml。在具体实施方案中,营养组合物的热量密度为约1kcal/ml至约3kcal/ml,包括约1.5kcal/ml至约3kcal/ml、约2kcal/ml至约3kcal/ml,或约2.5kcal/ml至约3kcal/ml。
在具体实施方案中,营养组合物是液体形式并具有约6至约8的pH,或者是粉末形式并在用水复溶后,形成具有约6至约8的pH的液体。在具体实施方案中,营养组合物是具有约6至约8的pH的粉末或液体补充剂。
在具体实施方案中,当营养组合物是液体、固体、半固体或粉末时(这包括当营养组合物包含粉末或液体补充剂时),所述组合物包含蛋白质、碳水化合物和/或脂肪。多种来源和类型的蛋白质、碳水化合物和脂肪可被用于本文所述的营养组合物的实施方案中。在具体实施方案中,当营养组合物包含粉末或液体补充剂时,该组合物包含以下中的零种、一种、两种或三种:蛋白质、碳水化合物和/或脂肪。
在如本文所述的营养组合物的具体实施方案中,当营养组合物包含液体、固体、半固体或粉末时(这包括但不限于当所述组合物包含粉末或液体补充剂时),所述营养组合物包含占所述营养组合物的约0重量%至约30重量%的蛋白质。在具体实施方案中,蛋白质占营养组合物的约0.1重量%至约25重量%,包括营养组合物的约0.5重量%至约20重量%、约1重量%至约15重量%、约1重量%至约10重量%、约5重量%至约10重量%或约10重量%至约20重量%。在具体实施方案中,蛋白质占营养组合物的约1重量%至约5重量%。在另外的具体实施方案中,蛋白质占营养组合物的约20重量%至约30重量%。
在营养组合物的具体实施方案中,当营养组合物包含液体、固体、半固体或粉末时(这包括但不限于当所述组合物包含粉末或液体补充剂时),一种或多种蛋白质来源被用于如本文所述的营养组合物中。例如,蛋白质来源可包括但不限于,完整、水解和/或部分水解的蛋白质,其可来源于适合的来源,诸如乳(如,酪蛋白、乳清)、动物(如,肉、鱼)、谷物(如大米、玉米)、蔬菜(如,大豆、豌豆)及其组合。蛋白质来源还可包括已知用于营养产品的氨基酸(常常被描述为游离氨基酸)的混合物或此类氨基酸与本文所述的完整、水解或部分水解的蛋白质的组合。所述氨基酸可以是天然存在的或合成的氨基酸。
当营养组合物包含液体、固体、半固体或粉末时(这包括但不限于当所述组合物包含粉末或液体补充剂时),营养组合物的具体实施方案中使用的蛋白质来源的更具体的实例包括但不限于,乳清蛋白浓缩物、乳清蛋白分离物、乳清蛋白水解物、酸性酪蛋白、酪蛋白酸钠、酪蛋白酸钙、酪蛋白酸钾、酪蛋白水解物、乳蛋白浓缩物、乳蛋白分离物、乳蛋白水解物、脱脂奶粉、浓缩脱脂奶、大豆蛋白浓缩物、大豆蛋白分离物、大豆蛋白水解物、豌豆蛋白浓缩物、豌豆蛋白分离物、豌豆蛋白水解物、胶原蛋白、胶原蛋白分离物、大米蛋白、马铃薯蛋白、蚯蚓蛋白、昆虫蛋白及其组合。
在营养组合物的具体实施方案中,当营养组合物包含液体、固体、半固体或粉末时(这包括但不限于当所述组合物包含粉末或液体补充剂时),所述组合物包含占营养组合物的约0重量%至约75重量%的量的碳水化合物。在具体实施方案中,碳水化合物以占营养组合物的约0.1重量%至约70重量%(包括占营养组合物的约0.5重量%至约65重量%、约10重量%至约65重量%、约20重量%至约65重量%、约30重量%至约65重量%、约40重量%至约65重量%,或约15重量%至约25重量%)的量存在。
当营养组合物包含液体、固体、半固体或粉末时(这包括但不限于当所述组合物包含粉末或液体补充剂时),如本文所述的营养组合物的具体实施方案中的碳水化合物包括简单的碳水化合物、复杂的碳水化合物,或其组合。适合于在本文所述的营养组合物的具体实施方案中使用的碳水化合物来源的非限制性实例包括HMO、麦芽糖糊精、水解淀粉、葡萄糖聚合物、玉米糖浆、玉米糖浆固体、大米来源的碳水化合物、蔗糖、葡萄糖、乳糖、蜂蜜、糖醇、异麦芽酮糖、舒可慢(sucromalt)、普鲁兰多糖、马铃薯淀粉、半乳寡糖、燕麦纤维、大豆纤维、玉米纤维、***树胶、羧甲基纤维素钠、甲基纤维素、瓜尔胶、结冷胶、刺槐豆胶、魔芋粉、羟丙基甲基纤维素、黄蓍胶、刺梧桐胶、***树胶、壳聚糖、***半乳聚糖(arabinoglactins)、葡甘露聚糖、黄原胶、海藻酸盐、果胶、低甲氧基果胶、高甲氧基果胶、谷类β-葡聚糖、角叉菜胶、车前草及其组合。
在具体实施方案中,当营养组合物包含液体、固体、半固体或粉末时(这包括但不限于当所述组合物包含粉末或液体补充剂时),所述组合物包含占营养组合物的约0重量%至约30重量%的脂肪。在某些具体实施方案中,脂肪占营养组合物的约0.1重量%至约30重量%,包括占营养组合物的约0.5重量%至约30重量%、约10重量%至约30重量%、约15重量%至约30重量%、约20重量%至约25重量%、约5重量%至约10重量%,或约10重量%至约20重量%。
在如本文所述的本发明的具体实施方案中,当营养组合物包含液体、固体、半固体或粉末时(这包括但不限于当所述组合物包含粉末或液体补充剂时),所述组合物包含一种或多种用于修饰营养组合物的物理、化学、美学或加工特性或用作附加营养组分的组分。附加组分的非限制性实例包括防腐剂、乳化剂(如卵磷脂)、缓冲剂、甜味剂(包括人造甜味剂(如糖精、阿斯巴甜、安赛蜜K、三氯蔗糖))、着色剂、调味剂、增稠剂、稳定剂等。
在如本文所述的营养组合物的具体实施方案中,当营养组合物包含液体、固体、半固体或粉末时(这包括但不限于当所述组合物包含粉末或液体补充剂时),所述组合物包含维生素和/或相关营养物,其非限制性实例包括维生素A、维生素B12、维生素C、维生素D、维生素K、硫胺素、核黄素、吡哆醇、烟酸、叶酸、泛酸、生物素、胆碱、肌醇、其盐和衍生物以及其组合。
在如本文所述的营养组合物的具体实施方案中,当营养组合物是液体、固体、半固体或粉末时(这包括当所述组合物包含粉末或液体补充剂时),所述组合物包含矿物质,其非限制性实例包括钙、磷、镁、锌、锰、钠、钾、钼、铬、铁、铜、氯化物及其组合。
CD被称为机会性病原体。肠道微生物群破坏后,CD在结肠中定殖并分泌两种毒素:毒素A和毒素B。这些毒素会导致严重的腹泻和结肠炎症,其可发展为危及生命的伪膜性结肠炎。经历一次发作的患者有20%的复发机会。
在具体实施方案中,其中本发明提供了如本文所述的包含液体、固体、半固体或粉末的营养组合物(包括当所述组合物包含粉末或液体补充剂时),所述组合物包含HMO、可发酵纤维和益生菌的独特组合;并提出了一种简单、廉价且安全的减少CD定植从而治疗CDI和/或降低CDI感染的可能性的方法。治疗方法的具体实施方案使用单独的如本文所述的营养组合物。治疗方法的其他具体实施方案将营养组合物与一种或多种其他CDI治疗物组合使用。
粉状营养组合物的具体实施方案包含按营养组合物的重量计的约0.01重量%至约10重量%范围内的岩藻糖基化HMO和/或约0.01重量%至约10重量%范围内的唾液酸化HMO。在一个更具体的实施方案中,岩藻糖基化HMO和唾液酸化HMO都包含在营养组合物中。营养组合物的具体实施方案还包含约0.1重量%至约25重量%范围内的不可消化的可发酵多糖和约10cfu/g至约109cfu/g范围内的双歧杆菌。
在另外的实施方案中,粉状营养组合物包含岩藻糖基化HMO和/或唾液酸化HMO,它们各自在占粉状营养组合物的至多约15%的范围(包括约0.01%至约15%,或约0.04至约14.9%,或约0.1重量%至约8重量%)内。在又一个替代实施方案中,粉状营养组合物包含各自在约1重量%至约6重量%的范围内的岩藻糖基化HMO和/或唾液酸化HMO。在每种此类组合物的更具体实施方案中,岩藻糖基化HMO和唾液酸化HMO都被包括在内。
在另外的实施方案中,粉状营养组合物包含范围为约0.1重量%至约20重量%,或约0.25%至约10%,或约0.3%至约8%,或约0.5%至约5%,或约5%至约15%的不可消化的可发酵多糖。
在另外的实施方案中,粉状营养组合物包含至多109cfu/g(包括约10cfu/g至约109cfu/g,或约102cfu/g至约107cfu/g,或约103cfu/g至约106cfu/g,或约104cfu/g至约106cfu/g的范围内的量)的如本文所述的益生菌或益生菌组合。例如,在具体实施方案中,粉状营养组合物包含至多109cfu/g(包括在约10cfu/g至约109cfu/g,或约102cfu/g至约107cfu/g,或约103cfu/g至约106cfu/g,或约104cfu/g至约106cfu/g的范围内的量)的双歧杆菌。
在具体实施方案中,营养组合物包含补充剂,该补充剂包含占补充剂的至多约50重量%的岩藻糖基化人乳寡糖和/或唾液酸化人乳寡糖、至少10重量%的不可消化的可发酵多糖和约5x102至约5x108cfu/g的至少一种如本文所述的益生菌(诸如双歧杆菌),并且补充剂不含具有至少约50%的聚合度小于约5的分子的短链果寡糖。在具体实施方案中,补充剂包含至多约50克(包括诸如约0克到约20克和约5克到约30克的范围)的总重量。
本发明的粉状营养组合物的又更具体的实例包含各约0.01重量%至约10重量%的2′-岩藻糖基乳糖(2’-FL)、6’-唾液酸乳糖(6′-SL)、玉米纤维和***树胶,以及约10至约109cfu/ml的双歧杆菌。具体实施方案另外含有2′FL、3′-岩藻糖基乳糖(3’FL)和/或乳糖-N-四糖(Lacto-N-Tetraose,LNT),它们是中性HMO。所述组合物的示例性酸性HMO是3’-唾液酸乳糖(3'SL)和6'-SL。
本发明的粉状营养组合物的又更具体的实例包含各占粉末的约0.01重量%至约15重量%的2-’FL、6’SL、玉米纤维和***树胶,和约10至约109cfu/g的双歧杆菌。另外的实施方案包含约1重量%至约10重量%的纤维。粉状营养组合物的具体实施方案包含至多约15重量%的玉米纤维,或约1重量%至约10重量%的玉米纤维,或约3重量%至约6重量%的玉米纤维。
液体营养组合物的另外具体实施方案包含约0.01重量%至约20重量%范围内的岩藻糖基化HMO和/或约0.01重量%至约20重量%范围内的唾液酸化HMO。液体营养组合物的另外具体实施方案包含各自在约0.01重量%至约20重量%,或约1.0重量%至约10.0重量%,或约0.01重量%至约5重量%的范围内的岩藻糖基化HMO和/或唾液酸化HMO。
液体营养组合物的具体实施方案还包含约0.1重量%至约5重量%范围内的不可消化的可发酵多糖和约10cfu/ml至约109cfu/ml范围内的双歧杆菌。在一个具体实施方案中,所述组合物同时包含岩藻糖基化HMO和唾液酸化HMO。
在替代实施方案中,液体营养组合物包含各自在约0.05重量%至约1.5重量%的范围内的岩藻糖基化HMO和/或唾液酸化HMO。在又替代实施方案中,液体营养组合物包含各自在约0.1重量%至约1重量%的范围内的岩藻糖基化HMO和/或唾液酸化HMO。
在另外的实施方案中,液体营养组合物包含约0.1重量%至约5重量%,或约0.5重量%至约4重量%,或约1重量%至约4重量%范围内的不可消化的可发酵多糖。在具体实施方案中,液体营养组合物包含在约0.1重量%至约5重量%,或约0.5重量%至约4重量%,或约1重量%至约4重量%,或约1.2重量%至约4重量%的范围内的含有玉米纤维的不可消化的可发酵多糖。
在另外的实施方案中,液体营养组合物包含约10cfu/ml至约109cfu/ml,或约102cfu/ml至约107cfu/ml,或约104cfu/ml至约106cfu/ml范围内的如本文所述的益生菌或益生菌组合。例如,在具体实施方案中,液体营养组合物包含约10cfu/ml至约109cfu/ml,或约102cfu/ml至约107cfu/ml,或约104cfu/ml至约106cfu/ml范围内的双歧杆菌。在另外的实施方案中,液体营养组合物包含至多约4x107cfu/ml(包括在约4x101cfu/ml至约4x107cfu/ml的范围内的量)的益生菌或益生菌组合。例如,在具体实施方案中,液体营养组合物包含至多约4x107cfu/ml(包括在约4x101cfu/ml至约4x107cfu/ml的范围内的量)的双歧杆菌。
在营养组合物的具体实施方案中,当营养组合物包含液体、固体、半固体或粉末时(这包括但不限于当所述组合物包含粉末或液体补充剂时),所述组合物不含具有至少约50%的聚合度小于约5的分子的scFOS。
在如本文所述的营养组合物的具体实施方案中,当营养组合物为液体、固体、半固体或粉末时(包括当所述组合物包含粉末或液体补充剂时),所述组合物包含以下中的一种或多种:益生菌(益生菌代谢物)、长链多不饱和脂肪酸(二十二碳六烯酸(DHA)、花生四烯酸(ARA)、二十二碳五烯酸(DPA)、二十碳五烯酸(EPA)等)、核苷酸、抗氧化剂/抗炎化合物(包括生育酚)、类胡萝卜素、抗坏血酸/维生素C、抗坏血酸棕榈酸酯、多酚(如姜黄素)、谷胱甘肽和超氧化物歧化酶(甜瓜)、人和/或牛乳来源的其他生物活性因子(如生长激素、细胞因子、转化生长因子(TGF)α或β)、人乳来源的脂质、游离氨基酸或肽(如,β-羟基-β-甲基丁酸酯(HMB)、精氨酸、亮氨酸和/或谷氨酰胺)、乳糖、水溶性或脂溶性维生素、矿物质和微量元素。
在本发明的方法中,向有患CDI风险、患有原发性CDI或患有复发性CDI的受试者施用本文所述的营养组合物。在具体实施方案中,受试者已被测试出对CD毒素A和/或B呈阳性,并且执行施用营养组合物的步骤是为了降低出现CDI的临床症状诸如腹泻和/或结肠炎症的风险。在具体实施方案中,将营养组合物施用给受试者以降低艰难梭菌原发感染或复发感染的风险。
在具体方法中,在施用本文所述的营养组合物之前、同时或之后向受试者施用抗生素和/或胃酸补充剂。在具体实施方案中,在施用营养组合物前约1天至约5天,或在施用营养组合物前约1天至约7天,或在施用营养组合物之前约1天至约14天,将抗生素和/或胃酸补充剂施用给受试者。在具体实施方案中,抗生素是万古霉素或非达霉素。
患有炎症和免疫缺陷的受试者有罹患CDI的风险。因此,在具体实施方案中,根据本发明方法施用本文所述的营养组合物的受试者患有炎性肠病、慢性肾病、免疫缺陷病、恶性病变,或已接受实体器官移植。
在具体实施方案中,将营养组合物每天一次或多次施用给受试者,持续至多约10周的时间段。在具体情况下,每天施用,持续约4周至约7周或约5周至约6周的时间段。在具体实施方案中,向受试者施用营养组合物,每周约1次至约6次,或每周约1次至约5次,或每周约1次至约4次,或每周约1次至约3次。
在具体实施方案中,营养组合物通过口服或经由管饲施用。在具体实施方案中,当经由管饲施用时,管饲是通过受试者的鼻子执行或者通过经受试者腹部中的切口直接施用到受试者的胃或小肠中来执行。
以下实施例展现本发明的方面。
实施例
型号
改编版本的体外肠道消化和发酵模型(如,PathoGut模型;ProDigest,Ghent,Belgium)用于评估成分和成分组合对艰难梭菌的潜在抗病原体活性。该模型测试了与初始CDI相关以及与CDI复发相关的成分和成分组合,并包括一系列模拟胃肠道不同部分的反应器。
更具体地说,体外肠道模型使用了三个在37℃下运行的反应器。反应器含有通过蠕动泵连接的双夹套玻璃容器。模拟胃和小肠中的消化的第一反应器遵循填充和抽取原理,其中每天添加3次确定的营养培养基和胰液和胆汁液。该培养基由复杂的碳水化合物和蛋白质来源、粘蛋白和矿物质和维生素组成。在第一隔室中消化后,浆液被泵入近端结肠(PC)(第二)反应器中,在那里开始结肠发酵。该模型还有远端结肠(DC)(第三)反应器。在恒定体积和pH控制下连续搅拌结肠反应器。
模拟PC的反应器含有被保持在约5.6至约5.9内的恒定pH下的500ml体积。DC反应器含有被保持在约6.6-6.9的恒定pH下的800ml体积。PC和DC反应器中的滞留时间和pH分别被设置为模拟PC和DC中的体内条件。
该模型利用了七个阶段或时期,如表1所示。在稳定期中,在PC和DC反应器中建立了CD微生物群落,其中群落根据PC和DC反应器环境不同的事实而变化。控制期被用于在每个隔室和反应器中建立CD水平的基线。在预防治疗期间,将如表2和表3中描述的成分施用给第一反应器,以观察对减少CD数量的影响。在克林霉素治疗期间,将抗生素克林霉素添加到DC和PC中以诱导生态失调。换句话说,克林霉素治疗导致微生物失衡,从而增加了CD取代其他微生物生物体并建立稳定CDI感染的机会。在克林霉素治疗期开始和结束时将CD孢子施用到PC中。在万古霉素治疗期间,将抗生素万古霉素施加至PC和DC中以模拟CDI的治疗。在随后的清除阶段,停止万古霉素施用,并测定CD数量。在清除期期间,在一些治疗物情况下会出现复发,并用其他治疗物来预防。
表1
将单个成分和成分组合以各种治疗组合物的形式用于模型中,以评价降低CDI发病率和提供治疗的能力。表2给出了治疗组合物中使用的特定寡糖、纤维和益生菌。
表2
更具体地,使用如表3所示的样品1-12。样品1和2包含对照(A和B),而样品3-12使用如所示的单个成分或各种成分组合来评价降低CDI发病率和提供CDI治疗的能力。每天一次用109CFU/g的贮液以533mg/天的水平施用益生菌(施用在表3中用“X”表示)。
表3
评估
结果在图1-12中示出。对于图1-12中的每一个,x轴示出与表1的阶段5-7一致的CDI阶段、万古霉素阶段(VNC)和清除阶段(WO)。数字1-4(即CDI 1、CDI 2等)表示给定阶段的周数,并且A、B和C表示在指定阶段的指定周内采集的各个样品。x轴的CDI阶段在克林霉素施用结束时开始,此时会诱导生态失调以建立CDI。CDI阶段为4周长(CDI 1至CDI 4),VNC阶段为1周长(VNC 1),并且清除阶段为3周长(WO 1至WO 3)。
y轴示出CDI第1周的孢子浓度或后几周/阶段的总活孢子计数(TVC)。添加CD孢子以在PC反应器内获得约4.6log CFU孢子/ml的所得孢子浓度。此水平是这样达到的:将在2ml溶液中的107CFU的CD孢子添加到PC反应器中的500ml溶液中,使孢子贮液被稀释250倍,从而在PC反应器内产生约4.6log CFU孢子/ml的浓度。
在用乙醇预处理样品后获得孢子计数。乙醇杀死营养CD细胞,而孢子被保留。总活孢子计数(TVC)是通过将样品直接涂铺在生长培养基上来获得的。由于体内感染通常发生在DC区中,因此通过将来自DC反应器的样品稀释液涂铺在选择性区分CD的生长培养基上来评估测试成分对CDI的影响。
图1和2例示了其中没有使用治疗成分的对照A和B,并例示了感染和复发时的基线CD水平。如图1和图2所例示,第一周对孢子计数,并在第3周开始观察到感染。4周CDI后,加入万古霉素,这使CD细胞计数降低到可检测水平以下。然而,如图1和2所例示,在每个对照实验中的第二个清除周中观察到如由TVC证实的感染复发。
所述治疗物中的两种,即分别如图3和图4所示的组合使用HMO、纤维2和3以及益生菌治疗以及单独使用益生菌的样品3和4能预防感染。然而,仅同时包含HMO、纤维2和3以及益生菌的样品3能预防复发,如图3所示。另一方面,如图4所示,在样品4的情况下,即当仅施用益生菌治疗时,在清除阶段发生感染复发。
图5-7分别示出了使用样品5-7的治疗,这些治疗没有预防最初的感染,但确实预防了复发。这包括用样品5,即HMO(图5)进行的治疗,用样品6,即纤维1、2和3的组合进行的治疗(图6),以及用样品7,即HMO与纤维2和3的组合进行的治疗(图7)。
图8-12示出了不能预防初始感染或复发的治疗物。这些治疗物包括:样品8,即HMO和纤维1、2和3(图8);样品9,即纤维1、2和3,和益生菌(图9);样品10,即HMO和益生菌(图10);样品11,即HMO和纤维1、2和3,和益生菌(图11);以及样品12,即纤维2和3(图12)。
对于使用样品5-12(图5-12)进行的实验性治疗,除了其中HMO和纤维2和3被组合使用的样品7(图7)的治疗与对照同时导致初始感染外,所有治疗物均延迟了初始感染时间。
令人惊讶的是,样品11(图11)包括HMO、纤维1、2和3和益生菌的组合。这与图3的相同,不同之处是在样品11(图11)中添加了纤维1(scFOS)。这表明scFOS抵消了图3的组合对CDI的影响。
本文描述的实施例仅是示例性的,并不限制由权利要求限定的本发明。
Claims (22)
1.一种营养组合物,其包含:
岩藻糖基化人乳寡糖和/或唾液酸化人乳寡糖;
不可消化的可发酵多糖;和
双歧杆菌;
其中所述营养组合物不含具有至少约50%的聚合度小于约5的分子的短链果寡糖。
2.一种治疗有罹患艰难梭菌感染风险的受试者或患有艰难梭菌感染的受试者的方法,所述方法包括:
向所述受试者施用营养组合物,其包含:
岩藻糖基化人乳寡糖和/或唾液酸化人乳寡糖;
不可消化的可发酵多糖;和
双歧杆菌;
其中所述营养组合物不含具有至少约50%的聚合度小于约5的分子的短链果寡糖。
3.如权利要求1所述的营养组合物或如权利要求2所述的方法,其中所述营养组合物包括粉状营养组合物,其包含按所述营养组合物的重量计:
约0.01重量%至约10重量%范围内的所述岩藻糖基化人乳寡糖和/或约0.01重量%至约10重量%范围内的所述唾液酸化人乳寡糖;
约0.1重量%至约25重量%范围内的所述不可消化的可发酵多糖;和
约10cfu/g至约109cfu/g范围内的所述双歧杆菌。
4.如权利要求1所述的营养组合物或如权利要求2所述的方法,其中所述营养组合物包括液体营养组合物,其包含:
约0.01重量%至约2重量%范围内的所述岩藻糖基化人乳寡糖和/或约0.01重量%至约2重量%范围内的所述唾液酸化人乳寡糖;
约0.1重量%至约5重量%范围内的所述不可消化的可发酵多糖;和
约10cfu/ml至约109cfu/ml范围内的所述双歧杆菌。
5.如权利要求1所述的营养组合物,其中所述营养组合物包括补充剂,其包含:
占所述补充剂的至多约50重量%的量的所述岩藻糖基化人乳寡糖和/或所述唾液酸化人乳寡糖;
基于所述补充剂的重量计的至少10重量%的所述不可消化的可发酵多糖;和
约5x102至约5x108cfu/g的所述双歧杆菌。
6.如前述权利要求中任一项所述的营养组合物或方法,其中所述营养组合物包含所述岩藻糖基化人乳寡糖和唾液酸化人乳寡糖。
7.如前述权利要求中任一项所述的营养组合物或方法,其中所述岩藻糖基化人乳寡糖是2’-岩藻糖基乳糖,并且所述唾液酸化人乳寡糖是6’-唾液酸乳糖。
8.如前述权利要求中任一项所述的营养组合物或方法,其中所述不可消化的可发酵多糖包括***树胶、玉米纤维,或***树胶和玉米纤维的组合。
9.如前述权利要求中任一项所述的营养组合物或方法,其中所述双歧杆菌包括动物双歧杆菌、短双歧杆菌、长双歧杆菌、婴儿双歧杆菌和/或两歧双歧杆菌。
10.如前述权利要求中任一项所述的营养组合物或方法,其中所述营养组合物进一步包含鼠李糖乳杆菌GG、鼠李糖乳杆菌HN001、嗜酸乳杆菌LA-5、嗜酸乳杆菌NCFM、发酵乳杆菌CECT5716、罗伊氏乳杆菌ATCC55730、罗伊氏乳杆菌ATCC PTA-6475、罗伊氏乳杆菌DSM17938,嗜热链球菌Th4,阿克曼氏菌属,拟杆菌属,肠球菌属,肠球菌属,真杆菌属,粪杆菌属,罗斯氏菌属和/或酵母菌属。
11.如前述权利要求中任一项所述的营养组合物或方法,其中所述营养组合物进一步包含抗炎化合物。
12.如权利要求2所述的方法,其中所述受试者患有艰难梭菌的原发感染。
13.如权利要求2所述的方法,其中所述受试者患有艰难梭菌的复发感染。
14.如权利要求2所述的方法,其中所述受试者已被测试出对艰难梭菌毒素A和/或B呈阳性,并且执行施用所述营养组合物的步骤是为了降低腹泻或结肠炎症的风险。
15.如权利要求2所述的方法,其中在施用所述营养组合物之前约1天至约7天,向所述有罹患艰难梭菌感染风险的受试者施用抗生素和/或胃酸补充剂。
16.如权利要求14所述的方法,其中向所述受试者施用抗生素,并且所述抗生素是万古霉素或非达霉素。
17.如权利要求2所述的方法,其中所述受试者患有炎性肠病、慢性肾病、免疫缺陷病、恶性病变,或者已接受实体器官移植。
18.如权利要求4所述的方法,其中将约237ml的所述液体营养组合物施用给所述受试者。
19.如权利要求2所述的方法,其中每天将所述营养组合物施用给所述受试者,持续约4周至约7周的时间段。
20.如权利要求2所述的方法,其中将所述营养组合物施用给所述受试者的步骤包括经由管饲施用所述营养组合物。
21.如权利要求2所述的方法,其中执行施用所述营养组合物的步骤是为了降低艰难梭菌原发感染的风险。
22.如权利要求2所述的方法,其中执行施用所述营养组合物的步骤是为了降低艰难梭菌复发感染的风险。
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